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Randomised clinical trial

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https://www.readbyqxmd.com/read/29778403/the-cf-sputum-induction-trial-cf-spit-to-assess-lower-airway-bacterial-sampling-in-young-children-with-cystic-fibrosis-a-prospective-internally-controlled-interventional-trial
#1
Katherine Ronchetti, Jo-Dee Tame, Christopher Paisey, Lena P Thia, Iolo Doull, Robin Howe, Eshwar Mahenthiralingam, Julian T Forton
BACKGROUND: Pathogen surveillance is challenging but crucial in children with cystic fibrosis-who are often non-productive of sputum even if actively coughing-because infection and lung disease begin early in life. The role of sputum induction as a diagnostic tool for infection has not previously been systematically addressed in young children with cystic fibrosis. We aimed to assess the pathogen yield from sputum induction compared with that from cough swab and single-lobe, two-lobe, and six-lobe bronchoalveolar lavage...
May 16, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29778344/impact-of-clinical-pharmacist-engagement-in-ward-teams-on-the-number-of-drug-related-readmissions-among-swedish-older-patients-with-dementia-or-cognitive-impairment-an-economic-evaluation
#2
Maria Sjölander, Lars Lindholm, Bettina Pfister, Jeanette Jonsson, Jörn Schneede, Hugo Lövheim, Maria Gustafsson
BACKGROUND: Clinical pharmacists play an increasing role in the pharmacological treatment of hospital-admitted older patients with dementia or cognitive impairment. In an earlier randomised controlled trial, clinical pharmacist involvement in the ward team could significantly reduce drug-related readmissions in patient subgroups. However, the economic impact of the intervention has not been addressed so far. OBJECTIVES: To evaluate the economic impact of clinical pharmacist engagement in hospital ward teams for medication therapy management in older patients with dementia or cognitive impairments...
May 16, 2018: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/29778325/tranexamic-acid-for-hyperacute-primary-intracerebral-haemorrhage-tich-2-an-international-randomised-placebo-controlled-phase-3-superiority-trial
#3
Nikola Sprigg, Katie Flaherty, Jason P Appleton, Rustam Al-Shahi Salman, Daniel Bereczki, Maia Beridze, Hanne Christensen, Alfonso Ciccone, Ronan Collins, Anna Czlonkowska, Robert A Dineen, Lelia Duley, Juan Jose Egea-Guerrero, Timothy J England, Kailash Krishnan, Ann Charlotte Laska, Zhe Kang Law, Serefnur Ozturk, Stuart J Pocock, Ian Roberts, Thompson G Robinson, Christine Roffe, David Seiffge, Polly Scutt, Jegan Thanabalan, David Werring, David Whynes, Philip M Bath
BACKGROUND: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. METHODS: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset...
May 15, 2018: Lancet
https://www.readbyqxmd.com/read/29777632/predictor-factors-for-long-term-outcomes-stability-of-coronally-advanced-flap-with-or-without-connective-tissue-graft-in-the-treatment-of-single-maxillary-gingival-recessions-9-years-results-of-a-randomised-controlled-clinical-trial
#4
Giulio Rasperini, Raffaele Acunzo, Gaia Pellegrini, Giorgio Pagni, Maurizio Tonetti, Giovan Paolo Pini Prato, Pierpaolo Cortellini
AIM: To assess the clinical outcomes 9 years after the surgical treatment of single maxillary gingival recessions and identify predictors for long-term gingival margin stability. MATERIALS AND METHODS: Twenty-five gingival recession (Miller Class I and II) were randomly treated with CAF plus CTG or CAF alone. Outcomes included Complete Root Coverage (CRC), Recession Reduction (REC), Keratinized Tissue (KT) gain and dentin hypersensitivity, and were evaluated at 6-month, 1-year and 9-year...
May 19, 2018: Journal of Clinical Periodontology
https://www.readbyqxmd.com/read/29777534/is-it-necessary-to-have-a-dentist-within-an-intensive-care-unit-team-report-of-a-randomised-clinical-trial
#5
Wanessa Teixeira Bellissimo-Rodrigues, Mayra Gonçalves Menegueti, Gilberto Gambero Gaspar, Hayala Cristina Cavenague de Souza, Maria Auxiliadora-Martins, Anibal Basile-Filho, Roberto Martinez, Fernando Bellissimo-Rodrigues
OBJECTIVE: To evaluate the effectiveness of dental treatment in improving oral health in critical patients. METHODS: This randomised clinical trial was conducted in a general intensive care unit (ICU) at a tertiary care public facility from 1 January 2011 to 8 August 2013. Data from 254 adult patients staying in the ICU for 48 hours or more were analysed. The experimental group (n = 127) had access to dental treatment provided by a dentist four to five times a week, in addition to routine oral hygiene, whereas the control group (n = 127) had access only to routine oral hygiene, including topical application of chlorhexidine, provided by the ICU nursing staff...
May 18, 2018: International Dental Journal
https://www.readbyqxmd.com/read/29776950/clinical-effects-and-safety-of-electroacupuncture-for-the-treatment-of-post-stroke-depression-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#6
Xue-Bin Li, Jie Wang, An-Ding Xu, Jian-Min Huang, Lan-Qing Meng, Rui-Ya Huang, Jing Xu
OBJECTIVE: The aim of this systematic review was to assess the efficacy/effectiveness and safety of electroacupuncture (EA) in the treatment of post-stroke depression (PSD). METHODS: A comprehensive literature search in the Pubmed, Embase, CENTRAL, ISI Web of Science, CNKI and Wanfang databases was conducted, and all relevant randomised controlled trials (RCTs) were screened for eligibility by two independent reviewers. The Cochrane Collaboration's tool and Jadad score were used to assess the risk of bias of included studies, and only RCTs scoring ≥3 were included in a meta-analysis...
May 18, 2018: Acupuncture in Medicine: Journal of the British Medical Acupuncture Society
https://www.readbyqxmd.com/read/29776475/a-systematic-review-of-the-psychometric-properties-of-the-modified-behavioral-pain-scale-mbps
#7
REVIEW
Dianne J Crellin, Franz E Babl, Nick Santamaria, Denise Harrison
PROBLEM: Clinicians and researchers require a valid way to assess procedural pain experienced by infants and children. The Modified Behavioral Pain Scale (MBPS) has been used to assess immunisation pain. However, it is unknown whether it is valid for this purpose and whether use can be extended to other procedures. The aim of this study was to rigorously assess evidence addressing the psychometric properties of this scale and to provide recommendations for its use. ELIGIBILITY CRITERIA: Psychometric evaluation studies reporting feasibility, reliability, validity, or utility data for the MBPS applied to children (birth to 18years) and randomised controlled trials (RCT) using the MBPS were included...
May 2018: Journal of Pediatric Nursing
https://www.readbyqxmd.com/read/29776444/mediastinal-staging-of-non-small-cell-lung-cancer-by-endobronchial-and-endoscopic-ultrasonography-with-or-without-additional-surgical-mediastinoscopy-mediastrial-study-protocol-of-a-multicenter-randomised-controlled-trial
#8
Jelle E Bousema, Marcel G W Dijkgraaf, Nicole E Papen-Botterhuis, Hermien W Schreurs, Jos G Maessen, Erik H van der Heijden, Willem H Steup, Jerry Braun, Valentin J J M Noyez, Fieke Hoeijmakers, Naomi Beck, Martijn van Dorp, Niels J M Claessens, Birgitta I Hiddinga, Johannes M A Daniels, David J Heineman, Harmen R Zandbergen, Ad F T M Verhagen, Paul E van Schil, Jouke T Annema, Frank J C van den Broek
BACKGROUND: In case of suspicious lymph nodes on computed tomography (CT) or fluorodeoxyglucose positron emission tomography (FDG-PET), advanced tumour size or central tumour location in patients with suspected non-small cell lung cancer (NSCLC), Dutch and European guidelines recommend mediastinal staging by endosonography (endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)) with sampling of mediastinal lymph nodes. If biopsy results from endosonography turn out negative, additional surgical staging of the mediastinum by mediastinoscopy is advised to prevent unnecessary lung resection due to false negative endosonography findings...
May 18, 2018: BMC Surgery
https://www.readbyqxmd.com/read/29776349/randomised-controlled-trial-rct-of-cannabinoid-replacement-therapy-nabiximols-for-the-management-of-treatment-resistant-cannabis-dependent-patients-a-study-protocol
#9
Anjali K Bhardwaj, David J Allsop, Jan Copeland, Iain S McGregor, Adrian Dunlop, Marian Shanahan, Raimondo Bruno, Nghi Phung, Mark Montebello, Craig Sadler, Jessica Gugusheff, Melissa Jackson, Jennifer Luksza, Nicholas Lintzeris
BACKGROUND: The cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches. METHODS/DESIGN: A phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment...
May 18, 2018: BMC Psychiatry
https://www.readbyqxmd.com/read/29775878/repositioning-of-diabetes-treatments-for-depressive-symptoms-a-systematic-review-and-meta-analysis-of-clinical-trials
#10
REVIEW
Calum D Moulton, Christopher W P Hopkins, Khalida Ismail, Daniel Stahl
Depression is a common comorbidity in diabetes but conventional antidepressant treatments do not consistently improve outcomes. We tested whether established diabetes treatments can also improve depressive symptoms and examined biological correlates of response. We performed a multi-database systematic search of all clinical trials, which measured the effect of licensed diabetes treatments on depressive symptoms using a validated questionnaire. Results of randomised controlled trials (RCT's) were pooled for meta-analysis...
May 7, 2018: Psychoneuroendocrinology
https://www.readbyqxmd.com/read/29774616/psychological-effects-of-belonging-to-a-facebook-weight-management-group-in-overweight-and-obese-adults-results-of-a-randomised-controlled-trial
#11
Monica Jane, Jonathan Foster, Martin Hagger, Suleen Ho, Robert Kane, Sebely Pal
This study was conducted to test whether the weight outcomes in an online social networking group were mediated by changes to psychological outcome measures in overweight and obese individuals, following a weight management programme delivered via Facebook. The data analysed in this study were collected during a three-armed, randomised, controlled clinical weight management trial conducted with overweight and obese adults over 24 weeks. Two intervention groups were given the same weight management programme: one within a Facebook group, along with peer support from other group members (the Facebook Group); the other group received the same programme in a pamphlet (the Pamphlet Group)...
May 18, 2018: Health & Social Care in the Community
https://www.readbyqxmd.com/read/29774176/pushing-the-limits-machine-preservation-of-the-liver-as-a-tool-to-recondition-high-risk-grafts
#12
REVIEW
Yuri L Boteon, Simon C Afford, Hynek Mergental
Purpose of the Review: Machine perfusion (MP) is a novel technology recently introduced in liver transplantation, redefining the current practice of organ preservation and pushing the limits of high-risk liver utilisation. This review highlights the key benefits of machine perfusion over conventional static cold storage (SCS), demonstrated in human liver research and clinical transplants. Recent Findings: The first clinical trials have demonstrated both safety and feasibility of MP...
2018: Current Transplantation Reports
https://www.readbyqxmd.com/read/29773699/comparison-of-the-effect-of-immediate-versus-delayed-transfer-following-a-stimulated-ivf-cycle-on-the-ongoing-pregnancy-rate-of-frozen-thawed-embryo-transfer-cycles-a-study-protocol-for-a-randomised-controlled-trial
#13
He Li, Lu Li, Xiang Lu, Xiaoxi Sun, Ernest Hung Yu Ng
INTRODUCTION: Frozen-thawed embryo transfer (FET) has become an increasingly important part of in-vitro fertilisation (IVF) treatment. Currently, there is still no good scientific evidence to support when to perform FET following a stimulated IVF cycle. Since all published studies are retrospective and the findings are contradictory, a randomised controlled study is needed to provide Level 1 evidence to guide the clinical practice. METHODS/ANALYSIS: This is a randomised controlled trial...
May 17, 2018: BMJ Open
https://www.readbyqxmd.com/read/29773696/electroacupuncture-as-a-complement-to-usual-care-for-patients-with-non-acute-low-back-pain-after-back-surgery-a-pilot-randomised-controlled-trial
#14
In Heo, Man-Suk Hwang, Eui-Hyoung Hwang, Jae-Heung Cho, In-Hyuk Ha, Kyung-Min Shin, Jun-Hwan Lee, Nam-Kwen Kim, Dong-Wuk Son, Byung-Cheul Shin
OBJECTIVES: The aim of this pilot study was to estimate the sample size for a large pragmatic study of the comparative effectiveness of electroacupuncture (EA) for low back pain (LBP) after back surgery. DESIGN: A randomised, active-controlled, assessor-blinded trial. PARTICIPANTS: Patients with recurrent or persistent LBP, defined as a Visual Analogue Scale (VAS) score of ≥50 mm, with or without leg pain after back surgery. INTERVENTIONS: Patients were randomised to an EA plus usual care (UC) group or to a UC alone group at a 1:1 ratio...
May 17, 2018: BMJ Open
https://www.readbyqxmd.com/read/29773539/effectiveness-of-text-message-based-diabetes-self-management-support-programme-sms4bg-two-arm-parallel-randomised-controlled-trial
#15
Rosie Dobson, Robyn Whittaker, Yannan Jiang, Ralph Maddison, Matthew Shepherd, Catherine McNamara, Richard Cutfield, Manish Khanolkar, Rinki Murphy
OBJECTIVE: To determine the effectiveness of a theoretically based and individually tailored, text message based, diabetes self management support intervention (SMS4BG) in adults with poorly controlled diabetes. DESIGN: Nine month, two arm, parallel randomised controlled trial. SETTING: Primary and secondary healthcare services in New Zealand. PARTICIPANTS: 366 participants aged 16 years and over with poorly controlled type 1 or type 2 diabetes (HbA1c ≥65 mmol/mol or 8%) randomised between June 2015 and November 2016 (n=183 intervention, n=183 control)...
May 17, 2018: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29773326/tremelimumab-combined-with-durvalumab-in-patients-with-mesothelioma-nibit-meso-1-an-open-label-non-randomised-phase-2-study
#16
Luana Calabrò, Aldo Morra, Diana Giannarelli, Giovanni Amato, Armida D'Incecco, Alessia Covre, Arthur Lewis, Marlon C Rebelatto, Riccardo Danielli, Maresa Altomonte, Anna Maria Di Giacomo, Michele Maio
BACKGROUND: Tremelimumab, an anti-CTLA4 monoclonal antibody, initially showed good activity when used alone in patients with mesothelioma, but did not improve the overall survival of patients who failed on first-line or second-line chemotherapy compared with placebo in the DETERMINE study. We aimed to investigate the efficacy and safety of first-line or second-line tremelimumab combined with durvalumab, an anti-PD-L1 monoclonal antibody, in patients with malignant mesothelioma. METHODS: In this open-label, non-randomised, phase 2 trial, patients with unresectable pleural or peritoneal mesothelioma received intravenous tremelimumab (1 mg/kg bodyweight) and durvalumab (20 mg/kg bodyweight) every 4 weeks for four doses, followed by maintenance intravenous durvalumab at the same dose and schedule for nine doses...
May 14, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29771279/peri-operative-therapy-for-operable-gastroesophageal-adenocarcinoma-past-present-and-future
#17
V Aggelis, D Cunningham, F Lordick, E C Smyth
Surgery represents the only chance of cure for patients with gastroesophageal adenocarcinoma; however surgery alone does not cure most patients. Over the past decade, several multimodality adjunctive treatments have improved survival for patients with operable gastroesophageal adenocarcinoma who are undergoing surgical resection; these include peri-operative chemotherapy, neoadjuvant chemoradiotherapy, adjuvant chemotherapy and adjuvant chemoradiotherapy. More recently, the results of several large randomised trials are leading to a shift in the peri-operative treatment of gastroesophageal cancer, away from anthracycline-based and towards taxane-based chemotherapy regimens...
May 16, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29770960/interventions-for-increasing-fruit-and-vegetable-consumption-in-children-aged-five-years-and-under
#18
REVIEW
Rebecca K Hodder, Kate M O'Brien, Fiona G Stacey, Rebecca J Wyse, Tara Clinton-McHarg, Flora Tzelepis, Erica L James, Kate M Bartlem, Nicole K Nathan, Rachel Sutherland, Emma Robson, Sze Lin Yoong, Luke Wolfenden
BACKGROUND: Insufficient consumption of fruits and vegetables in childhood increases the risk of future non-communicable diseases, including cardiovascular disease. Interventions to increase consumption of fruit and vegetables, such as those focused on specific child-feeding strategies and parent nutrition education interventions in early childhood may therefore be an effective strategy in reducing this disease burden. OBJECTIVES: To assess the effectiveness, cost effectiveness and associated adverse events of interventions designed to increase the consumption of fruit, vegetables or both amongst children aged five years and under...
May 17, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29770466/comparative-evaluation-of-the-effects-of-withania-somnifera-with-pentoxifylline-on-the-sperm-parameters-in-idiopathic-male-infertility-a-triple-blind-randomised-clinical-trial
#19
R Nasimi Doost Azgomi, H Nazemiyeh, H Sadeghi Bazargani, S M B Fazljou, F Nejatbakhsh, A Moini Jazani, Y Ahmadi AsrBadr, A Zomorrodi
In this triple-blind randomised clinical trial, we compared the effects of Withania somnifera and pentoxifylline on the sperm parameters in idiopathic male infertility. One hundred infertile male patients were randomly allocated into either W. somnifera or pentoxifylline groups. Patients in the herbal group received six capsules containing 5 g/daily of W. somnifera root, and subjects in the pentoxifylline group received six capsules containing 800 mg/daily of pentoxifylline and placebo for 90 days. Sperm parameters were analysed at the beginning and end of the study...
May 16, 2018: Andrologia
https://www.readbyqxmd.com/read/29769296/interpreting-risk-reduction-in-clinical-trials-for-pulmonary-arterial-hypertension
#20
REVIEW
Annie C Lajoie, Sébastien Bonnet, Yves Lacasse, Jean-Christophe Lega, Steeve Provencher
Because of scepticism concerning study results when relying solely on relative effect estimates, the number needed to treat (NNT) has been used extensively to quantify the net clinical benefit of an intervention, and is reported increasingly in randomised trials and observational studies. This method is a simple measure representing the number of patients who would need to be treated to prevent one additional adverse event. However, like relative risk, the NNT is an inherently time-dependent measure. Thus, its calculation may lead to misleading interpretations, especially for studies involving varying follow-up times or recurrent outcomes...
June 30, 2018: European Respiratory Review: An Official Journal of the European Respiratory Society
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